1. Scrip
  2. >>Focus On Asia
  3. >>India

Industry Sponsored Trials Fall Sharply In Challenging Indian Environment

 
• By Deborah Jeanfavre

A rise in bureaucracy and increased liability for clinical trial sponsors have impacted the popularity of India as a location for pharmaceutical companies’ clinical studies. Trialtrove’s Deborah Jeanfavre examines the data, which show a continuing decrease in new industry-sponsored trials starting in India over the past five years.

Grunge India flag.
• Source: Shutterstock

The rosy view of India as a location for relatively low-cost clinical trials with a readily available, treatment-naïve patient population became shaded over the past five years by an untenable time to approval. With the prolonged online review process, combined with increased liability for sponsors and other trial-related restrictions by the Indian government, it is not surprising that India became a less attractive clinical trial location to pharma. (Also see "NIH confirms cut-back in Indian trials but large sponsors hope for reform" - Scrip, 18 July, 2013.) Taking a look in Trialtrove, we examined industry-sponsored study starts in India in the aftermath of these regulations, drilling down to explore the effect across major therapeutic areas, sponsors and diseases.

Multiple factors have contributed to an increased approval time in India during the last 5 years. The country transitioned to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from India

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making forecasting for the pharma industry extremely difficult, Scrip finds in this infographic analysis

Aurobindo Expects Lannett Acquisition To Pass FTC Scrutiny; Q1 US Revenue Falls

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.

Cipla Revs Up Biosimilars Engine Amid Winds Of Regulatory Change

 
• By Anju Ghangurde

Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.

More from Focus On Asia

Aurobindo Expects Lannett Acquisition To Pass FTC Scrutiny; Q1 US Revenue Falls

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.

Multiple Factors Driving Japan’s Pioneering Angiosarcoma Pipeline

 
• By Lisa Takagi

Japan has emerged as a global leader in the development of new drugs for the rare cancer angiosarcoma, reflecting its rapidly ageing population and the limitations of current therapies.